NCT02752737

Brief Summary

Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
5,385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
38 countries

163 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 2, 2016

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2024

Completed
Last Updated

July 30, 2025

Status Verified

February 1, 2025

Enrollment Period

8.6 years

First QC Date

April 25, 2016

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months

    Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System

    12 Months

  • Freedom from Atrial Arrhythmia at 12 Months

    Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System.

    12 Months

  • Freedom from Arrythmias at 12 months

    Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters.

    12 Months

  • Freedom from Device / Procedure Related Adverse Events

    Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months.

    12 Months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 18 years or older with a planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter.

You may qualify if:

  • Subject is ≥ 18 years of age or minimum age as required by local regulations
  • Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter
  • Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

You may not qualify if:

  • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (163)

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503-2560, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Doylestown Health Cardiology

Doylestown, Pennsylvania, 18901, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705-1852, United States

Location

Texas Health Research & Education Institute

Dallas, Texas, 75231, United States

Location

Instituto Cardiovascular de Buenos Aires (ICBA)

Buenos Aires, C1428DCO, Argentina

Location

Institituo Cardiovascular Buenos Aires (ICBA)

Buenos Aires, CP:1428, Argentina

Location

Hospital Universitario Fundación Favaloro

Buenos Aires, Argentina

Location

Kepler Universitätsklinikum Med Campus III.

Linz, 4021, Austria

Location

Centre Hospitalier Régional de la Citadelle

Liège, Liege, 4000, Belgium

Location

Onze-Lieve-Vrouwziekenhuis-Campus Aalst

Aalst, Belgium

Location

Gleneagles Jerudong Park Medical Centre

Bandar Seri Begawan, Brunei, BG3122, Brunei

Location

Clínica Dávila

Santiago, Chile

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100037, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Tianjin Chest Hospital

Tianjin, 300051, China

Location

Fundacion Clinica Shaio

Bogotá, Colombia

Location

Clinica Ces

Medellín, Colombia

Location

Nemocnice Na Homolce

Prague, 150 30, Czechia

Location

Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

Location

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Segeberger Kliniken GmbH - Herzzentrum

Bad Segeberg, 23795, Germany

Location

Sana Klinikum Lichtenberg

Berlin, 10365, Germany

Location

Städtische Kliniken Bielefeld

Bielefeld, 33604, Germany

Location

Klinikum Coburg GmbH

Coburg, 69450, Germany

Location

St. Vinzenz-Hospital Köln

Cologne, 50733, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, 60389, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, 58515, Germany

Location

Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus

Mönchengladbach, 41063, Germany

Location

Städtische Kliniken München GmbH - Klinikum Bogenhausen

München, Germany

Location

Oberschwaben-Klinik GmbH - Krankenhaus St. Elisabeth

Ravensburg, 88212, Germany

Location

St. Josephs Hospital Wiesbaden

Wiesbaden, 65189, Germany

Location

Hellenic Airforce 251 General Hospital

Athens, 11525, Greece

Location

Gottsegen György Országos Kardiológiai Intézet

Budapest, Hungary

Location

Debreceni Egyetem

Debrecen, Hungary

Location

Landspitali - National Hospital of Iceland

Reykjavik, Iceland, 108, Iceland

Location

Aster Medcity

Kochi, Kerala, 682027, India

Location

Sree Chitra Tirunal Institute for Medical Sciences & Technology

Thiruvananthapuram, Kerala, 695011, India

Location

Eternal Hospital

Jaipur, Rajasthan, 302017, India

Location

Apollo Hospital (Chennai)

Chennai, Tamil Nadu, 600006, India

Location

Aig Hospital

Hyderabad, India

Location

Max Super Speciality Hospital

New Delhi, 110017, India

Location

National Cardiovascular Center Harapan Kita

Jakarta, 11420, Indonesia

Location

National Cardiovascular Center Harapan Kita

Jakarta, Indonesia

Location

Humanitas Mater Domini

Castellanza, 21053, Italy

Location

Fondazione IRCCS Policlinico San

Pavia, Italy

Location

Ospedale S. Maria della Misericordia

Perugia, 06129, Italy

Location

Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

Pisa, 56100, Italy

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, 814-0001, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Gifu, 503-8502, Japan

Location

Hiroshima City Hospital

Hiroshima, Hiroshima, 730-8518, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, 734-8530, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Hokkaido Ohno Memorial Hospital

Sapporo, Hokkaido, 063-0052, Japan

Location

Caress Sapporo Hokko Memorial Hospital

Sapporo, Hokkaido, 065-0027, Japan

Location

Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaraki, 300-0028, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Japanese Red Cross Wakayama Medical Center

Wakayama, Kansai, 640-8558, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, 880-0834, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, Osaka, 530-0001, Japan

Location

Osaka Rosai Hospital

Sakai, Osaka, 591-8025, Japan

Location

Osaka General Medical Center

Sumiyoshi-ku, Osaka, 558-8558, Japan

Location

Tokyo University Hospital

Bunkyo-Ku, Tokyo, 113-8655, Japan

Location

Sakakibara Heart Institute

Fuchū, Tokyo, 183-0003, Japan

Location

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Japan

Location

Kansai Rosai Hospital

Amagasaki, Japan

Location

Anjo Kosei Hospital

Anjo, Japan

Location

Tokyo Medical and Dental University, Medical Hospital

Bunkyō City, 113-8519, Japan

Location

Nippon Medical School Hospital

Bunkyō City, Japan

Location

Chiba University Hospital

Chiba, Japan

Location

Tokai University Hachioji Hospital

Hachiōji, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Japan

Location

Hirosaki University Hospital

Hirosaki, 036-8563, Japan

Location

Hiroshima City Hospital

Hiroshima, Japan

Location

Kanazawa University Hospital

Ishikawa, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Japan

Location

National Hospital Organization Kagoshima MC

Kagoshima, Japan

Location

Kokura Kinen Hospital

Kitakyushu, 802-8555, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

Dokkyo Medical University Saitama Medical Center

Koshigaya, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

The Jikei University School of Medicine Hospital

Minatoku, Japan

Location

Kyorin University Hospital

Mitaka, Japan

Location

Mie Heart Center

Miwa, Japan

Location

Nagoya City University East Medical Center

Nagoya, Japan

Location

Kochi Medical School Hospital

Nankoku, Japan

Location

Kurashiki Central Hospital

Okayama, Japan

Location

Kindai University Hospital

Ōsaka-sayama, 589-8511, Japan

Location

Toho University Omori Medical Center

Ōta-ku, Japan

Location

Kitasato University Hospital

Sagamihara, Japan

Location

Japanese Red Cross Saitama Hospital

Saitama, 330-8553, Japan

Location

Sendai City Hospital

Sendai, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Japan

Location

Tenri Hospital

Tenri, Japan

Location

Showa University Toyosu Hospital

Tokyo, 135-8577, Japan

Location

Tokyo Medical Center

Tokyo, Japan

Location

Tokyo Metropolitan Hiroo Hospital

Tokyo, Japan

Location

Toyama Prefectural Central Hospital

Toyama, Japan

Location

Fujita Health University Hospital

Toyoake, Japan

Location

University of Tsukuba Hospital

Tsukuba, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Yokkaichi Municipal Hospital

Yokkaichi, Japan

Location

Yokohama City Minato Red Cross Hospital

Yokohama, 231-8682, Japan

Location

University of Fukui Hospital

Yoshida, Japan

Location

National Research Cardiac Surgery Center

Astana, Kazakhstan

Location

Salman Al Abdallah Al Dabbous Cardiac Center (DCC) - Al Adan Hospital

Al Ahmadi, Kuwait

Location

Chest Diseases Hospital

Kuwait City, Kuwait

Location

Cardiac Vascular Sentral Kuala Lumpur (CVSKL)

Kuala Lumpur, Malaysia, 50470, Malaysia

Location

Sarawak Heart Centre

Kuching, Sarawak, 94300, Malaysia

Location

Hospital Serdang

Sepang, Selangor, 43000, Malaysia

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Hospital Angeles Lomas

Huixquilucan, State of Mexico, 52763, Mexico

Location

Centro Médico Nacional Siglo XXI

Mexico City, 06720, Mexico

Location

Hospital San Angel Inn Universidad

México, 03330, Mexico

Location

The Royal Hospital

Muscat, Oman

Location

Saint Lukes Medical Center (SLMC)

City of Taguig, National Capital Region, 1634, Philippines

Location

The Medical City

Pasig, National Capital Region, 1603, Philippines

Location

Spital Wojewodzki nr 2

Rzeszów, Poland, 35-301, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland

Location

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, Poland

Location

Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie

Rzeszów, Poland

Location

Centro hospitalar Vila Nova de Gaia/Espinho-Unidade I

Vila Nova de Gaia, 4434-502, Portugal

Location

Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN

Moscow, Russia

Location

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Russia

Location

State Budgetary Healthcare Institution of Sverdlovsk region for "Sverdlovsk Regional Clinical Hospital #1"

Yekaterinburg, 620102, Russia

Location

King Fahad Medical City (KFMC)

Riyadh, 11433, Saudi Arabia

Location

Institute for Cardiovascular Disease (ICVD) Dedinje

Belgrade, Serbia, 11040, Serbia

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

Banská Bystrica, 97401, Slovakia

Location

Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

Bratislava, 83348, Slovakia

Location

Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

Košice, 04011, Slovakia

Location

Netcare Sunninghill Hospital

Johannesburg, South Africa

Location

Busamed Gateway Hospital

Umhlanga, 4319, South Africa

Location

Seoul National University Bundang Hospital

Seoul, Gyeonggi-do, 463-707, South Korea

Location

Hallym University Sacred Heart Hospital

Seoul, 152-703, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Hospital Universitario Moncloa

Madrid, 28008, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan, 10491, Taiwan

Location

Cheng-Hsin General Hospital

Taipei, Taiwan, 112, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Siriraj Hospital

Bangkok, Thailand, 10700, Thailand

Location

Phramongkutklao Hospital

Bangkok, Thailand

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

Location

Sheikh Khalifa Medical City

Abu Dhabi, United Arab Emirates

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE7 7DN, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

St George's University Hospitals - NHS Trust

London, SW17 0QT, United Kingdom

Location

St. George's Hospital-NHS Trust

London, SW17 0QT, United Kingdom

Location

St. Bartholomew's Hospital

London, United Kingdom

Location

Related Publications (9)

  • Abdrakhmanov A, Nuralinov O, Rashbayeva G, Tursunbekov A, Bagibayev S, Bakytzhanuly A, Yessilbayev Z, Chinybayeva A, Abdrakhmanova Z, Salustri A, Suleymen Z, Kirkimbayeva R. Cryoballoon ablation for the treatment of atrial fibrillation in Kazakhstan: One year outcome from the Cryo Global Registry. Indian Pacing Electrophysiol J. 2025 Sep-Oct;25(5):294-301. doi: 10.1016/j.ipej.2025.06.008. Epub 2025 Jun 20.

  • Khelae SK, Chun KRJ, Drephal C, Scazzuso F, Kueffer FJ, van Bragt KA, Lawrenz T, Todd D, Ptaszynski P, Foldesi C. Real-world sex differences in healthcare utilization after cryoballoon ablation: 2-year outcomes from the Cryo Global Registry. Front Cardiovasc Med. 2025 Jun 3;12:1549002. doi: 10.3389/fcvm.2025.1549002. eCollection 2025.

  • Lawin D, Stellbrink C, Chun KJ, Li CH, van Bragt KA, Kueffer F, Selma JM, Oh IY, Herzet JM, Nitta J, Chang TY, Lawrenz T. Impact of atrial fibrillation diagnosis-to-ablation time on 24-month efficacy and safety outcomes in the Cryo Global Registry. Europace. 2025 Feb 5;27(2):euaf008. doi: 10.1093/europace/euaf008.

  • Ahn H, Lim HE, On YK, Selma JM, Kueffer FJ, van Bragt KA, Obidigbo V, Oh IY. Long-term Outcome of Cryoballoon Ablation in Korean Patients With Atrial Fibrillation: Real-World Experience From the Cryo Global Registry. Korean Circ J. 2024 Oct;54(10):619-633. doi: 10.4070/kcj.2024.0044. Epub 2024 Jun 10.

  • Lawin D, Lawrenz T, Chun KRJ, Lim HE, Obidigbo V, Selma JM, Peytchev P, Nguyen DQ, Foldesi C, Stellbrink C; the Cryo AF Global Registry Investigators. Cryoballoon ablation of atrial fibrillation in octogenarians: one year outcomes from the cryo global registry. J Interv Card Electrophysiol. 2024 Sep;67(6):1341-1351. doi: 10.1007/s10840-023-01680-z. Epub 2023 Dec 12.

  • Scazzuso F, Ptaszynski P, Kaczmarek K, Chun KRJ, Khelae SK, Foldesi C, Obidigbo V, van Bragt KA, On YK, Al-Kandari F, Okumura K; Cryo Global Registry Investigators. Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry. J Interv Card Electrophysiol. 2024 Apr;67(3):493-501. doi: 10.1007/s10840-023-01582-0. Epub 2023 Jul 28.

  • Zucchelli G, Chun KRJ, Khelae SK, Foldesi C, Kueffer FJ, van Bragt KA, Scazzuso F, On YK, Al-Kandari F, Okumura K; Cryo Global Registry Investigators. Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry. J Interv Card Electrophysiol. 2023 Apr;66(3):711-722. doi: 10.1007/s10840-022-01388-6. Epub 2022 Nov 4.

  • Lim HE, Oh IY, Kueffer FJ, van Bragt KA, On YK. Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry. Korean Circ J. 2022 Oct;52(10):755-767. doi: 10.4070/kcj.2022.0127. Epub 2022 Aug 12.

  • Rordorf R, Scazzuso F, Chun KRJ, Khelae SK, Kueffer FJ, Braegelmann KM, Okumura K, Al-Kandari F, On YK, Foldesi C; Cryo AF Global Registry Investigators. Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Patients With Concomitant Heart Failure and Either Reduced or Preserved Left Ventricular Ejection Fraction: Results From the Cryo AF Global Registry. J Am Heart Assoc. 2021 Dec 21;10(24):e021323. doi: 10.1161/JAHA.121.021323. Epub 2021 Dec 10.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Khaldoun Tarakji, MD

    Medtronic CAS Chief Medical Officer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

April 27, 2016

Study Start

May 2, 2016

Primary Completion

November 29, 2024

Study Completion

November 29, 2024

Last Updated

July 30, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations